One dragonfly optis imaging catheter was received for evaluation.A hoop and the syringe were also returned.The results of the investigation confirmed that the returned catheter was able to be purged as normal, after the dried contrast was removed via water bath, with no air bubbles, leaks, or anomalies noted.Dimensional inspection revealed the purge hole diameter also met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the returned condition of the device and the information received, the cause of the reported event remains unknown.
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